Fortum - referral

Current status

European Commission final decision

Overview

The European Medicines Agency has completed a review of Fortum. The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that there is a need to harmonise the prescribing information for Fortum in the European Union (EU).

What is Fortum?

Fortum is a medicine that contains the active substance ceftazidime. It is used to treat bacterial infections caused mainly by 'aerobic Gram-negative bacteria'.

The active substance, ceftazidime, is a 'beta-lactam' antibiotic of the group 'cephalosporins'. It works by attaching to proteins on the surface of bacteria. This prevents the bacteria from building their cell walls, and eventually kills them.

Fortum is also available in the EU under other trade names: Cefortam, Ceftim, Fortumset, Glazidim, Panzid, Potendal and Solvetan.

The company that markets these medicines is GlaxoSmithKline.

Why was Fortum reviewed?

Fortum is authorised in the EU via national procedures. This has led to divergences across Member States in the way the medicine can be used, as seen in the differences in the summaries of product characteristics (SmPCs), labelling and package leaflets in the countries where the medicine is marketed.

Fortum was identified as needing harmonisation by the Co-ordination Group on the Mutual and Decentralised Procedures – Human (CMD(h)).

On 24 March 2009, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Fortum in the EU.

What are the conclusions of the CHMP?

The CHMP, in the light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SmPCs, labelling and package leaflets should be harmonised across the EU.

The areas harmonised include:

4.1 Therapeutic indications

The CHMP agreed that Fortum should be used to treat the following infections:

• nosocomial pneumonia (pneumonia caught in hospital)
• broncho-pulmonary infections (infection affecting the lungs) in patients with cystic fibrosis
• bacterial meningitis (inflammation of the membranes that surround the brain and spinal cord)
• chronic suppurative otitis media (infection of the middle ear with the formation of pus)
• malignant otitis externa (a severe infection of the outer ear and surrounding bone and tissue)
• complicated urinary tract infections
• complicated skin and soft tissue infections
• complicated intra-abdominal infections (infections within the abdomen)
• bone and joint infections
• peritonitis (inflammation of peritoneum lining the abdominal cavity) in patients undergoing 'continuous ambulatory peritoneal dialysis'.

Fortum may also be used to:

• treat bacteraemia (bacteria in the blood) that is associated with or suspected to be associated with the infections listed above;
• manage patients with neutropenia (with low levels of neutrophils, a type of white blood cell) who also have fever suspected to be caused by bacterial infection;
• prevent urinary tract infections for patients undergoing 'trans-urethral resection of the prostate (TURP)'.

When using Fortum, prescribers should take into account the fact that the medicine works mainly against aerobic Gram-negative bacteria. The medicine should therefore be used together with other antibacterial medicines if the infection is also thought to involve bacteria against which Fortum will not be effective.

4.2 Posology and method of administration

The Committee also agreed on specific dose ranges for adults and children for the various infections.

4.3 Contra-indications

Fortum should not be used in patients who are hypersensitive (allergic) to ceftazidime, to any other cephalosporin or to any other ingredients of the medicine. It must also not be used in patients with a history of severe hypersensitivity (allergic reactions) to any other type of beta-lactam antibiotics (penicillins, monobactams and carbapenems).

Other changes

The Committee also harmonised other sections of the SmPC including the sections on special warnings and pregnancy and lactation.

The amended information to doctors and patients is available in the 'All documents' tab.

Questions and answers on Fortum and associated names (ceftazidime powder for solution for infusion or injection, 250 mg, 500 mg, 1 g, 2 g, 3 g)

Reference Number: EMA/659330/2010

Key facts

About this medicine

• Approved name:
  Fortum
• International non-proprietary name (INN) or common name:
  ceftazidime
• Associated names:
  • Cefortam
  • Glazidim
  • Panzim
  • Solvetan

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/H/A-30/001006
• Type:
  Article 30 referrals

  This type of referral is triggered when Member States have adopted different decisions over the years for some medicines (e.g. different indications, contraindications or posology) and there is a need to harmonise across the EU.

Key dates and outcomes

• CHMP opinion date:
  21/10/2010
• EC decision date:
  13/01/2011

All documents

Fortum - Article 30 referral - Annex III

Questions and answers on Fortum and associated names (ceftazidime powder for solution for infusion or injection, 250 mg, 500 mg, 1 g, 2 g, 3 g)

Reference Number: EMA/659330/2010

Description of documents published

Please note that some of the listed documents apply only to certain procedures.

• Overview - lay-language summary of the stage of the procedure
• Notification – a letter from a Member State, the European Commission or the marketing authorisation holder requesting the initiation of the procedure
• Scientific background – further background information from the triggering Member State on the issues leading to the initiation of the procedure (if applicable)
• List of questions – questions agreed by the Committee requesting further information from the marketing authorisation holder(s) / applicant(s) to evaluate the issues identified
• Timetable for the procedure – agreed timeframe to respond to the list of questions, to assess the issues and to adopt a conclusion
• List of medicines concerned by the procedure – medicine(s) / active substance(s) concerned, and marketing authorisation holder(s) / applicant(s)
• List of questions to be addressed by the stakeholders – call for data to be submitted by stakeholders (e.g. healthcare professionals, patient organisations, individual patients) (if applicable)
• Stakeholder submission form – form to be used by stakeholders to submit data (if applicable)
• Scientific conclusions – scientific conclusions of the PRAC and/or CHMP and/or CMDh
• Assessment report – PRAC or CHMP assessment and conclusions on the issues investigated, including divergent positions (if applicable)
• Divergent positions – divergent positions of the CHMP or CMDh members for pharmacovigilance procedures (if applicable)
• Changes to the summary of product characteristics, labelling and package leaflet (amended sections or fully revised version) (if applicable)
• Condition(s) to the marketing authorisation(s) – condition(s) for the safe and effective use of the medicine(s) (if applicable)
• Condition for lifting the suspension – condition to be fulfilled for the suspension of the marketing authorisation(s) to be lifted (if applicable)
• Timetable for implementation of CMDh position – agreed timeframe to submit and finalise the variation(s) implementing the outcome of the procedure (if applicable)

Note that older documents may have different titles.